Randomised induction and post induction therapy in older patients (greater than or equal to 61 years of age) with Acute Myelocytic Leukaemia (AML) and Refractory Anaemia with Excess of Blasts (RAEB, RAEB-t)

Phase 3

Completed

• Conditions: Acute Myeloid Leukaemia (AML); Cancer; Myeloid leukaemia

• Registration Number: ISRCTN77039377
• Lead Sponsor: Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)

Brief Summary

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19776405 2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20103782

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2005-11-01
• Study Start: 2005-12-20
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

1. Age 61 years or more
2. Subjects with a cytopathologically confirmed diagnosis of AML (M0-M2 and M4-M7, FAB classification), or with Refractory Anaemia with Excess of Blasts (RAEB) or Refractory Anaemia with Excess of Blasts in transformation (RAEB-t) with an International Prognostic Scoring System (IPSS) score of greater than or equal to 1.5
3. Subjects with a secondary AML progressing from antecedent Myelodysplasia (MDS) and biphenotypic leukemia are eligible. Antecedent MDS refers to any antecedent haematological disease of at least four month duration
4. World Health Organisation (WHO) performance status less than or equal to two
5. Written informed consent

Exclusion Criteria

1. Previous induction treatment for AML/MDS
2. Prior chemotherapy within six months of study entry
3. Previous polycythemia rubra vera
4. Primary myelofibrosis
5. Blast crisis of chronic myeloid leukemia
6. AML-FAB type M3 or AML with cytogenetic abnormality t(1517) translocation
7. Impaired hepatic or renal function as defined by:
a. Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) greater than 25 x normal value
b. Bilirubin greater than 2 x normal value
8. Serum creatinine greater than 2 x normal value (after adequate hydration), unless these are most likely caused by AML organ infiltration
9. Concurrent severe and/or uncontrolled medical condition (e.g., uncontrolled diabetes, infection, hypertension, etc.,)
10. Cardiac dysfunction as defined by:
10.1. myocardial infarction within the last six months of study entry, or
10.2. reduced left ventricular function with an ejection fraction less than or equal to 50% as measured by Multiple Gated Acquisition (MUGA) scan or echocardiogram (another method for measuring cardiac function is acceptable)
11. Unstable angina
12. Unstable cardiac arrhythmias

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endpoint for the comparison of induction treatment arm B with arm A:<br>Event-free survival (i.e. time from registration to induction failure, death or relapse whichever occurs first); the time to failure of patients with induction failure is set at one day.<br><br>Endpoint for the comparison of post induction maintenance treatment with GO with no further treatment: disease-free survival measured from the date of second randomisation to relapse or death from any cause.